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Clinical Trials/NCT01872741
NCT01872741
Unknown
Not Applicable

Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.

University of Sao Paulo General Hospital0 sites58 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Aneurysm
Sponsor
University of Sao Paulo General Hospital
Enrollment
58
Primary Endpoint
Atrophy degree measurement (temporal muscle)
Last Updated
12 years ago

Overview

Brief Summary

This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms

Detailed Description

This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms. Overall, 60 eligible patients admitted with ruptured and unruptured anterior circulation aneurysms will enrolled in the study. The aesthetic results will be analyzed with 2 methods. In the first, the patients will be showed to a rule, with a scale from 0 to 100, in which 0 mean the best result and 100 the worst result. Photos will be taken and showed to two independent observers, the results will be classified as excellent, good, regular or poor. The degree of atrophy will be measured with three methods. In the first one, the authors wiil observes the percentage of thick reduction in the temporal muscle, subcutaneous tissue and skin. In the second method the percentage thick reduction of the isolated temporal muscle will be measured and the third the volumetric analysis of the temporal muscle, subcutaneous tissue and skin will be calculated from the superior edge of zygomatic arch to superior temporal line. The functional results wiil be compared using the Modified Rankin Score. Others variables such frontal facial palsy, post-operative hemorrhage, cerebrospinal fistulas, hydrocephalus and mortality will be also analyzed

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leonardo C. Welling

MD, Post graduation programm

University of Sao Paulo General Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of intracranial aneurysms

Exclusion Criteria

  • Giant aneurysms Intracranial hematomas

Outcomes

Primary Outcomes

Atrophy degree measurement (temporal muscle)

Time Frame: 6 months

The degree of atrophy was measured with three methods. In the first one, the authors observed the percentage of thick reduction in the temporal muscle, subcutaneous tissue and skin. In the second method the percentage thick reduction of the isolated temporal muscle was observed. Both measures were made in the beginning of the sphenoid wing. The volumetric analysis of the temporal muscle, subcutaneous tissue and skin was calculated from the superior edge of zygomatic arch to superior temporal line using the OsiriX software

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